体细胞基因突变检测系统
PMA编号：P120022 · 2021-07-07
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申请人QIAGEN GmbH
决定日期2021-07-07
PMA 编号P120022
产品代码OWD
设备分类第3类
医疗专科U
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
器械摘要
Somatic gene mutation detection system is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2021-07-07. The device is classified under product code OWD. It was reviewed by the PA advisory panel.
常见问题
What is the Somatic gene mutation detection system?
Somatic gene mutation detection system is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is QIAGEN GmbH.
When did Somatic gene mutation detection system receive FDA 510(k) clearance?
The clearance date for Somatic gene mutation detection system can be found in the official FDA records.
Who is the listed applicant for Somatic gene mutation detection system?
FDA 510(k)记录显示QIAGEN GmbH为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Somatic gene mutation detection system?
The FDA product code for Somatic gene mutation detection system is OWD.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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